2014 ERP New Member Book

AOACO FFICIAL M ETHODS OF A NALYSIS (2012)

V OLUNTARY C ONSENSUS S TANDARDS AppendixG, p. 3

( b ) Guidance and support can be obtained from the AOAC TechnicalDivision onReferenceMaterials. D. Single-LaboratoryValidation ( a ) Data demonstrating response linearity, accuracy, repeatability, LOD/LOQ, and matrix scope must be present. Experimental designs to collect this datamayvarywith themethod protocol and the intended use of themethod. ( b ) Resources can be identified by the AOAC Statistics Committee. E. Reproducibility/Uncertainty andProbabilityof Detection ( a ) Forquantitativemethods,datademonstratingreproducibility and uncertainty must be present. Experimental designs to collect thisdatamayvarywith themethodprotocol, available laboratories, and the intended use of the method (i.e., collaborative studies, proficiency testing, etc.). ( b ) Forqualitativemethods, datamust bepresent demonstrating the probability of detection at specified concentration levels as defined by the SMPR. Experimental designs to collect this data may varywith themethod protocol, available laboratories, and the intended use of themethod. ( c ) Guidance and support can be obtained from the AOAC StatisticsCommittee. F. Comparison toSMPR ( a ) Documentmethodperformance versus SMPR criteria.Note whichSMPR criteria aremet. For SMPR criteria notmet, theERP documents the reasoningwhy themethod is still acceptable. ( b ) Data is present to assure the matrix and analyte scopes are covered. This is critical formethods used for dispute resolutions. G. Feedback fromUsersofMethod ( a ) Document positive and negative feedback from users of the method during the trial period. ( b ) Feedback from users demonstrating method ruggedness should be documented. ( c ) Assess the future availability of vital equipment, reference materials, and supplies. H. ERPRecommendations toRepeal FirstActionMethods Recommendations to repeal First Action methods shall be accompaniedwith detailed reasons for the decision. TheFirst toFinal Action guidance for ERPswas approved by the OMB inDecember 2011 and effective as of February 1, 2012.

FirstAction toFinalActionMethods: Guidance forAOACExpert ReviewPanels

InDecember2011, theOfficialMethodsBoard (OMB) approved a guidance document for ERPs to support their work as they deliberate on methods, adopt methods as Official First Action, and, subsequently, track method usage and performance between FirstAction statusandFinalActionconsideration. Theguideline is basedonparameters of amethod that theOMBwill considerwhen deliberating on methods recommended for Final Action status. ERPs are to use this guideline in their deliberations. ERPs working within the AOAC process may recommend a FirstAction statusmethod be elevated toFinalAction status. Such a recommendation leverages the ERP’s high level of expertise supported by data from the initial evaluation, and results from the subsequent 2-yearmethod performance evaluation period. The OMB receives the recommendation with supporting documentation, and determines if FinalAction status iswarranted. OMB’s review verifies the method process was conducted in compliancewith the guidelines and protocols of theAssociation. For transparency and to expedite the review process, the main areasOMBwill reviewwhen evaluatingERP recommendations to promotemethods to FinalAction are listed below. Documentation of the areas listed belowwill also increase confidence in method performance and assist users to properly and safely perform the ( a ) Amethod’s applicability to the identified stakeholder needs is best assessed by the stakeholder panel and should be a part of the process from the onset. OMB liaisons will remind stakeholder panels tomaintain this focus point. ( b ) OMBmay askERPs and stakeholder panels for feedback to improve the applicability of themethod, such as potential method scope expansions and potential points of concern. B. SafetyConcerns ( a ) A safety review must be performed for a method to be recognized as FirstAction. ( b ) All safety concerns identified during the 2-year evaluation periodmust be addressed. ( c ) Guidance and support can be obtained from the AOAC SafetyCommittee. C. ReferenceMaterials ( a ) Document efforts undertaken to locate reference materials. Methods may still progress to Final Action even if reference materials are not available. methods at their locations. A. MethodApplicability

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